Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

Completed

• Conditions: Idiopathic Nephrotic Syndrome
• Interventions: Genetic: DNA chip dedicated to the pharmacogenetic of steroids

• Registration Number: NCT01609426
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The primary purpose of the study is to identify the factors of steroid dependency in childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the first manifestation. Different clinical and biological factors will be analyzed: age of first manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization in the Parisian area, genoprevalence of herpes viruses and polymorphisms in the genes involved in the response to steroid therapy.

Detailed Description

Patients with a steroid dependent nephrotic syndrome will be compared to those with a non steroid dependent form of nephrotic syndrome at the end of the first manifestation. An additional blood volume will be sampled in patients and controls during a scheduled biological check-up for the initial disease. Genetics factors will be checked using a DNA chips devoted to the response to steroid therapy and viral genome of EBV, CMV, HHV7 will be searched for using PCR reaction in total blood DNA extract.

Study Timeline

• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-05-30
• Study First Posted: 2012-06-01
• Study Start: 2012-09
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

Inclusion Criteria

• children below 16 years
• first manifestation of nephrotic syndrome
• steroid sensitivity according to the recommendations of the french "pediatric society nephrology"

Exclusion Criteria

• patients who don't stay in Paris during the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
children with idiopathic nephrotic syndrome	DNA chip dedicated to the pharmacogenetic of steroids	children below 16 years of age with a steroid dependent nephrotic syndrome

Primary Outcome Measures

Name	Time	Method
define pharmacogenetic factors of steroid dependency	28.5 months

Secondary Outcome Measures

Name	Time	Method
Dynamic of the epidemiology of idiopathic nephrotic syndrome in the Paris Area	28.5 months	Number of participants with idiopathic nephrotic syndrome in Paris Area to determinate if clusters cases exist.
parameters of the immune response against herpesvirus, specially the cellular production of interferon induced by specific viral peptides	28.5 months
Analysis of cortico-dependence factors	Day 1	Comparison of polymorphisms of cortico-dependent patients with non- cortico-dependent patients
Analysis of susceptibility factors that generate the appearance of the Idiopathic Nephrotic Syndrome	Day 1	Comparison of polymorphisms of all patients suffering from the Idiopathic Nephrotic Syndrome, with general population

Trial Locations

Locations (1)

APHP Robert-Debré, Department of Pediatric Nephrology; 🇫🇷 Paris, France